28 Apr Third Wave seeks pre-market approval for HPV testing technology
Madison, Wis. – Third Wave Technologies has submitted pre-market approval applications for its two human papillomavirus, or HPV testing products to the U.S. Food and Drug Administration.
The submission of Third Wave’s two HPV applications is based on the strength of the clinical trial data for its single-instrument testing solution, according to Kevin Conroy, chief executive for Third Wave. The data was collected during the recently completed clinical trial of genotyping tests for Third Wave’s 14-type high-risk HPV and 16/18 HVP, which cause approximately 70 percent of all cervical disease.
HPV tests are being developed as a primary screen for cervical cancer in women, and could replace Pap testing.
The clinical trial, initiated in early 2006, screened more than 50,000 subjects and enrolled over 3,400 subjects, including more than 1,300 women with atypical Pap test results.
Third Wave expects to be in market with the instrument in 2009, when the global market for HPV testing is projected to be approximately $250 million. Third Wave expects market growth to continue in excess of 25 percent in the near term.
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